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537
A Science-Based Endeavor: Interpreting Contamination Prevention in The Food Safety Modernization Act
Shauna Manion*
Table of Contents
I. INTRODUCTION ..................................................................................... 537 II. BACKGROUND....................................................................................... 539
A. A Brief History of Food Safety Regulation in America ............... 539 B. The FDA Food Safety Modernization Act ................................... 544
III. ANALYSIS ............................................................................................. 549 A. Agency Deference ........................................................................ 550 B. Textualism.................................................................................... 552 C. Intentionalism .............................................................................. 554 D. Purposivism.................................................................................. 560
IV. CONCLUSION ........................................................................................ 561
I. INTRODUCTION
On January 4, 2011, President Barack Obama signed the FDA Food
Safety Modernization Act (the “Act”)1 into law, enacting the largest
overhaul of the food industry since the Federal Food, Drug, and
Cosmetics Act of 1938.2 In granting the Food and Drug Administration
(FDA) greater systematic oversight of all food production facilities,3 the
Act authorizes the FDA to implement prevention standards to combat
* J.D. Candidate, The Dickinson School of Law of the Pennsylvania State University, 2013; B.A., University of Wisconsin Madison, 2010. I would like to thank Professors Adam Muchmore and Stephen Ross for their advice in this writing process. I would especially like to thank my parents, Greg and Joanne, and sisters Kerry, Bridgid, and Jillian for their constant support, perspective, and humor. 1. FDA Food Safety Modernization Act, Pub. L. No. 111-353, 124 Stat. 3885 (2011) (codified in scattered sections of the U.S. Code). 2. See, e.g., Les Schnoll, The Food Safety Modernization Act: A Public Health Imperative—Why New Legislation is Necessary, QUALITYDIGEST.COM (Aug. 30, 2011), http://www.qualitydigest.com/inside/fda-compliance-column/food-safety-modernization-act-public-health-imperative.html 3. See 124 Stat. 3885.
538 PENN STATE LAW REVIEW [Vol. 117:2
food contamination outbreaks.4 Specifically, Title I, Section 103 of the
Act, mandates that the FDA “establish science-based minimum
standards” to conduct hazard analysis and employ preventative controls.5
Although this directive seems straightforward, the term “science-based”
represents the only qualitative description of the regulations that the Act
contains.6
The Act’s pervasive impact on the food industry will likely cause
food production companies and public health advocates to scrutinize
both the guidance documents7 and the final promulgated regulations
thoroughly.8 The U.S. Supreme Court has held
9 that agency construction
of statutes the agency administers must conform to congressional intent
if that intent is clear.10
Various methods of statutory construction serve
to ascertain congressional intent, including an assessment of the plain
meaning of the statute’s text, analysis of the legislative history, and
examination Congress’s underlying purpose.11
This Comment uses these
4. See Background on the FDA Food Safety Modernization Act (FSMA), U.S. FOOD
& DRUG ADMIN. (July 19, 2011), http://www.fda.gov/downloads/Food/FoodSafety/ FSMA/UCM263773.pdf. 5. Federal Food, Drug, & Cosmetic Act § 418(n)(1)(A), 21 U.S.C. § 350g(n)(1)(A) (2011). 6. See id. 7. Federal Food, Drug, & Cosmetic Act § 701(h), 21 U.S.C. § 371(h) (2006 & Supp. 2011). 8. See Mike Adams, Senate Bill S 510 Vote Imminent—Procedural Vote Passes 74-25, NATURALNEWS.COM, Nov. 18, 2010, http://www.naturalnews.com/030440_ Food_Safety_Modernization_Act_Senate.html (outlining organizations opposed to the Senate version of the Act). 9. See Chevron U.S.A., Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837, 842 (1984) (“If the intent of Congress is clear, that is the end of the matter; for the court as well as the agency must give effect to the unambiguously expressed intent of Congress.”); see also Estate of Cowart v. Nicklos Drilling Co., 505 U.S. 469, 475 (1992) (citing Demarest v. Manspeaker, 498 U.S. 184, 190 (1991)) (holding that the judiciary is the final authority on issues of statutory construction and must reject administrative constructions which are contrary to clear congressional intent). 10. Chevron further held that “when a statute is silent or ambiguous with respect to the specific question, the issue for the court is whether the agency’s answer is based on a permissible construction of the statute.” Chevron, 467 U.S. at 842. The Supreme Court later clarified this language in holding that reasonable, permissible, or rational constructions are accorded Chevron deference. See Holly Farms Corp. v. N.L.R.B., 517 U.S. 392, 398 (1996); Kristine Cordier Karnezis, Annotation, Construction and Application of “Chevron Deference” to Administrative Action by United States Supreme Court, 3 A.L.R. FED. 2D 25 (2005). However, the question of whether “science-based” is rational construction under the Act is beyond the scope of this Comment. This Comment will solely examine clear congressional intent and proper adherence to this intent. 11. See William N. Eskridge, Jr. & Philip P. Frickey, Statutory Interpretation as Practical Reasoning, 42 STAN. L. REV. 321, 324 (1990); see also Lawrence M. Solan, Private Language, Public Laws: The Central Role of Legislative Intent in Statutory Interpretation, 93 GEO. L.J. 427 (2005); Peter L. Strauss, The Courts and the Congress: Should Judges Disdain Political History?, 98 COLUM. L. REV. 242 (1998); Caleb Nelson, What Is Textualism?, 91 VA. L. REV. 347 (2005).
2012] A SCIENCE-BASED ENDEAVOR 539
methods to clarify the term “science-based,” establishing some definition
to the regulations the FDA should promulgate in order to withstand a
challenge in court.
This Comment’s analysis of the plain language of the text indicates
the importance of objective standards and use of the scientific method.
Examination of the legislative history of the Act demonstrates that
legislators understood “science-based” to connote use of experts and in-
plant evaluations similar to that enumerated in Hazard Analysis and
Critical Control Point (HACCP) methodology, data collection similar to
that employed by the Food Safety and Inspection Service, and
information technology utilization as advocated by the FDA Science
Board. Additional examination of Congressional purpose reveals
legislators expected “science-based” regulations to comply with World
Trade Organization Sanitary and Phytosanitary standards. Taken
together, these methods of statutory interpretation12
provide a clearer
view of Congress’s “science-based” regulatory mandate to the FDA.
II. BACKGROUND
A. A Brief History of Food Safety Regulation in America
The history of food regulation in America and the problems with
food safety persisting today explain Congress’s motivation in writing and
passing the FDA Food Safety Modernization Act. Consequently, to
understand the potential impact of this Act, it is important to discuss the
historical development of food safety regulation law in the United States.
Food safety regulation in the United States began slowly, but public
outcry over unsanitary meat products in the early 20th century resulted in
the passage of the Pure Food and Drug Act of 1906.13
This legislation
was limited in its ability to adapt to the modernizing food industry, and
in 1938, Congress enacted the Federal Food, Drug, and Cosmetics Act.14
An examination of these Acts15
and later history of food safety measures
12. Although various other theories of statutory interpretation exist, this Comment focuses on “archeological” theories to ascertain congressional intent. See William N. Eskridge, Jr., Gadamer/Statutory Interpretation, 90 COLUM. L. REV. 609, 611 (1990). 13. See DONNA J. WOOD, STRATEGIC USES OF PUBLIC POLICY: BUSINESS AND
GOVERNMENT IN THE PROGRESSIVE ERA 70 (Edwin M. Epstein ed., 1986) (discussing how muckraking journalists brought unsanitary meat production conditions to public attention)); see also Pure Food and Drug Act, Pub. L. No. 59-384, 34 Stat. 768 (1906). 14. See Vincint A. Kleinfeld, Legislative History of the Federal Food, Drug, and Cosmetic Act, 50 Food & Drug L.J. 65, 67 (1995); see also Federal Food, Drug, and Cosmetics Act, Pub. L. No. 75-717, 52 Stat. 1040 (1938). 15. The Acts discussed in this Comment also contain implications for drug, cosmetic, and medical device regulation; however, this Comment will focus on developments in food safety.
540 PENN STATE LAW REVIEW [Vol. 117:2
in America will help to clarify legislative intent in adopting the FDA
Food Safety Modernization Act and the nature of the safety plans that the
FDA must administer.
Prior to the 20th century, the U.S. Federal Government regulated
food production and distribution to a minimal extent.16
In the late 1800s,
public awareness of health hazards in the food industry dramatically
increased.17
Contaminated food, milk, and water caused many food-
borne infectious diseases during this time, including typhoid fever,
tuberculosis, and scarlet fever.18
Muckraking journalists, most notably,
Upton Sinclair, brought these unsanitary food production conditions to
light.19
Sinclair’s novel, The Jungle, provided a vivid description of the
unsanitary and inhumane conditions in the Chicago meatpacking
industry, shocking readers.20
One foul description read:
[T]he meat would be shoveled into carts, and the man who did the
shoveling would not trouble to lift out a rat even when he saw one—
there were things that went into the sausage in comparison with
which a poisoned rat was a tidbit. There was no place for the men to
wash their hands before they ate their dinner, and so they made a
practice of washing them in the water that was to be ladled into the
sausage. There were the butt-ends of smoked meat, and the scraps of
corned beef, and all the odds and ends of the waste of the plants, that
would be dumped into old barrels in the cellar and left there. Under
the system of rigid economy which the packers enforced, there were
some jobs that it only paid to do once in a long time, and among these
was the cleaning out of the waste barrels. Every spring they did it;
and in the barrels would be dirt and rust and old nails and stale
water—and cartload after cartload of it would be taken up and
dumped into the hoppers with fresh meat, and sent out to the public’s
breakfast.21
16. See Significant Dates in U.S. Food and Drug Law History, U.S. FOOD & DRUG
ADMIN. (Oct. 14, 2010), http://www.fda.gov/AboutFDA/WhatWeDo/History/ Milestones/ucm128305.htm. 17. See id. 18. See JAMES HARVEY YOUNG, PURE FOOD: SECURING THE FEDERAL FOOD AND
DRUGS ACT OF 1906 40 (1989). 19. See WOOD, supra note 13, at 70. 20. James Harvey Young, The Pig That Fell into the Privy: Upton Sinclair’s The Jungle and the Meat Inspection Amendments of 1906, 59 BULL. OF THE HIST. OF MED. 467, 467 (1985) (detailing how the history of The Jungle helped to spur passage of the 1906 Food and Drugs Act). 21. UPTON SINCLAIR, THE JUNGLE 162 (Penguin Books 2006) (1906).
2012] A SCIENCE-BASED ENDEAVOR 541
In response to these types of writings, American meat purchases, both
domestic and foreign, fell by one-half.22
As a result, Congress passed the
Pure Food and Drug Act23
and the Meat Inspection Act in 1906.24
The Pure Food and Drug Act of 1906 (the “1906 Act”) represented
the first wave of regulation over food production.25
The 1906 Act
prohibited the adulteration or misbranding of food.26
Specifically, the
1906 Act deemed food to be adulterated if “any substance has been
mixed or packed with it so as to reduce or lower or injuriously affect its
quality or strength,” or “if it contain[ed] any added poisonous or other
added deleterious ingredient which may render such article injurious to
health.”27
The 1906 Act considered food to be misbranded if it was
“labeled or branded as to deceive or mislead the purchaser,” or if “the
contents [were] stated in weight or measure, they [were] not plainly and
correctly stated on the outside of the package.”28
In addition, the 1906
Act tasked the Bureau of Chemistry with the responsibility of examining
food for mislabeling or alterations.29
The Bureau of Chemistry, however, struggled to meet its new
responsibilities.30
The 1906 Act did not provide the Bureau of Chemistry
any new staff or funding.31
Furthermore, judicial decisions narrowed the
capacity of the Bureau of Chemistry to enforce the statute by requiring
high standards for proof of fraudulent intent.32
Under the framework of
the 1906 Act, the government did not have “the power simply to
22. See PHILIP J. HILTS, PROTECTING AMERICA’S HEALTH: THE FDA, BUSINESS, AND
ONE HUNDRED YEARS OF REGULATION 51 (2003). 23. Pure Food and Drug Act, Pub. L. No. 59-384, 34 Stat. 768 (1906) (codified in scattered sections of the U.S. Code). 24. Federal Meat Inspection Act, Pub. L. No. 59-382, 34 Stat. 669 (1906) (codified in scattered sections of the U.S. Code). 25. See HILTS, supra note 22, at 56. 26. 34 Stat. 768. 27. Id. 28. Id. 29. See Wallace Janssen, Outline of the History of U.S. Drug Regulation and Labeling, 36 FOOD DRUG COSM. L.J. 420, 425 (1981). 30. See HILTS, supra note 22, at 56 (observing that the Bureau of Chemistry found it difficult to meet the Congressional mandates of the Pure Food and Drug Act of 1906 because of the way in which the Act was worded, and the lack of resources allocated to the Bureau). 31. Id. 32. See, e.g., United States v. Lexington Mill & Elevator Co., 232 U.S. 399 (1914) (holding that the burden falls on the government to show a relationship between the chemical additive and the harm it allegedly caused in people, and that the mere presence of such additives is not sufficient to render the food illegal); see also United States v. Forty Barrels & Twenty Kegs of Coca-Cola, 241 U.S. 265 (1916) (holding that the introduction of caffeine in the later stages of syrup production made it an “added ingredient” in any sense of the term and the removal of harmful ingredients, even if vital to the identity of the product, did not constitute adulteration).
542 PENN STATE LAW REVIEW [Vol. 117:2
determine that the law was violated; it required that the government take
each offender to court and prove that each particular food . . . was
adulterated or mislabeled, and by what standard it was making that
judgment.”33
In an attempt to better fulfill the goals of the 1906 Act, the Bureau
of Chemistry’s regulatory powers were reorganized under a new
Department of Agriculture body, the “Food, Drug, and Insecticide
Administration,” later shortened to the “Food and Drug Administration”
(FDA).34
But this reorganization could not overcome the 1906 Act’s
shortcomings.35
According to one scholar, “The 1906 [Act] was built on
the idea that false claims must be prosecuted, rather than addressing the
real issues of whether food. . .put on the market [was] safe. . . .”36
By the 1930s, the weaknesses of the 1906 Act prompted the FDA to
recommend that Congress enact a completely revised bill.37
The need to
enact new legislation became accentuated after an untested product,
Elixir Sulfanilamide, caused the deaths of 107 people in 1937.38
Ultimately, Congress passed the Food, Drug, and Cosmetic Act in 1938
(the “1938 Act”).39
In the 1938 Act, Congress provided detailed
provisions that restricted adulteration and misbranding of food.40
Whereas the 1906 Act did not establish definitions or standards of food
identity, the 1938 Act authorized administrative establishment of these
definitions.41
Pursuant to the 1938 Act, if a quality standard was
established for a particular food and that food fell below the standard, the
food must be labeled as sub-standard or be held misbranded.42
The 1938
Act also deemed a product to be misbranded if “its container is so made,
formed, or filled as to be misleading.”43
Selling one food under the name
of another was also prohibited by the 1938 Act.44
The 1938 Act
authorized authority to promulgate standards of fill for containers, and
prohibited substances added to make “the product appear better or of
greater value than it is.”45
The 1938 Act also established the remedy of
33. HILTS, supra note 22, at 54. 34. Id. at 74. 35. See id. at 68. 36. HILTS, supra note 22, at 68. 37. See Significant Dates in U.S. Food and Drug Law History, supra note 16. 38. See id. 39. See id. 40. David F. Cavers, The Food, Drug, and Cosmetic Act of 1938: Its Legislative History and Its Substantive Provisions, 6 LAW & CONTEMP. PROBS. 2, 25 (1939). 41. See id. at 25. 42. See id. at 29. 43. See id. at 30. 44. See id. at 29. 45. Id. at 27.
2012] A SCIENCE-BASED ENDEAVOR 543
court injunctions and authorized factory inspections.46
The 1938 Act was
a milestone in American food safety oversight and continues to serve as
the basic food safety statute today.47
The FDA’s forceful administration of the 1938 Act contributed to
the legislation’s success, and judicial interpretations of the 1938 Act
tended to strengthen and broaden the FDA’s power.48
In the 1950s and
1960s, the FDA was widely successful in bringing hundreds of lawsuits
against nutrition claims that it viewed as false or misleading.49
With this
new power, the FDA also established food standards and lists of
ingredients that could lawfully be included in products.50
A series of
laws addressing pesticide residue, food additives, and color additives
gave the FDA tighter control over chemicals that may enter the food
market.51
In addition, manufacturers had the duty to establish the safety
of such chemicals.52
Subsequent amendments to the 1938 Act addressed additional food
safety concerns.53
The Miller Amendment of 1948 affirmed that the
FDA had the authority to regulate goods crossing state lines that had
reached the consumer.54
The Food Additives Amendment of 1958
required manufacturers to establish the safety of new food additives, and
the FDA published the first list of substances generally recognized as
46. See Significant Dates in U.S. Food and Drug Law History, supra note 16. 47. See Wallace F. Janssen, The Story of the Laws Behind the Labels, U.S. FOOD &
DRUG ADMIN. (Oct. 23, 2010), http://www.fda.gov/AboutFDA/WhatWeDo/ History/Overviews/ucm056044.htm. 48. See CHARLES O. JACKSON, FOOD AND DRUG LEGISLATION IN THE NEW DEAL 220 (1970); see also Kordel v. United States, 335 U.S. 345 (1948) (holding that product literature which met the product at the location of the sale constitutes labeling and is thus subject to the labeling provisions of the 1938 Act even though such literature did not physically accompany the product); United States v. Urbuteit, 335 U.S. 355 (1948) (same). 49. See Peter Barton Hutt & Peter Barton Hutt II, A History of Government Regulation of Adulteration and Misbranding of Food, 39 FOOD DRUG COSM. L.J. 2, 67 (1984) (citing V.E. Irons, Inc. v. United States, 244 F. 2d 34 (1st Cir. 1957); United States v. Nutrition Serv., Inc. 227 F. Supp. 375 (W.D. Pa. 1964)). 50. See JACKSON, supra note 48, at 22. In the years following the 1938 Act, food technology advanced and the number of possible ingredients grew exponentially. Id. In response, the FDA developed recipe standards for foods, which included lists of ingredients that could lawfully be included in a product. Id. If food products varied from the lawful recipes, they would have to be labeled as an imitation. Id. 51. See JACKSON, supra note 48, at 220. 52. See MELVIN J. HINICH AND RICHARD STAELIN, CONSUMER PROTECTION
LEGISLATION AND THE U.S. FOOD INDUSTRY 34 (1980). 53. See Janssen, supra note 47. 54. Miller Amendment, 21 U.S.C. § 350e (1948); Color Additives Amendment, 21 U.S.C. § 379e (1960) (requiring manufacturers of new food and color additives to establish that the additives are safe); Fair Packaging and Labeling Act, 15 U.S.C. § 1451 (1966) (requiring all consumer products in interstate commerce to be honestly and informatively labeled).
544 PENN STATE LAW REVIEW [Vol. 117:2
safe in the same year.55
Similarly, the Color Additive Amendment of
1960 required manufacturers to establish the safety of food color
additives.56
In 1988, Congress designated the FDA as an agency within
the U.S. Department of Health and Human Services, with a
Commissioner appointed by the President.57
Thus, as the 20th century
progressed, the FDA acquired significant responsibility in food safety
regulation.58
B. The FDA Food Safety Modernization Act
Despite the FDA’s expanded responsibilities and authority, the
agency continued to struggle against preventing food contamination
outbreaks.59
Each year in the United States, about 48 million people get
sick, 128,000 are hospitalized, and 3,000 die as a result of foodborne
diseases.60
The lack of preventative measures became especially
pronounced during the summer of 2010 with various publicized
contamination events.61
These outbreaks resulted in the recall of half a
billion eggs that caused salmonella, and a peanut butter recall connected
to food poisoning.62
Shortly after these outbreaks, the push for
preventative measures to protect against food contamination grew among
consumer groups and various members of Congress.63
Although congressional efforts to advance preventative measures
enjoyed some bipartisan support, the ultimate product, the FDA Food
Safety Modernization Act (the “Act”), did not pass through Congress
55. Food Additives Amendment, 21 U.S.C. § 348 (1958). 56. Color Additives Amendment, 21 U.S.C. § 379e (1958 & Supp. 1960). 57. See Significant Dates in U.S. Food and Drug Law History, supra note 16. 58. See HILTS, supra note 22. 59. See RENÉE JOHNSON, CONG. RESEARCH SERV., R40403, FOOD SAFETY IN THE
111TH CONGRESS 1 (2010). 60. U.S. FOOD & DRUG ADMIN., supra note 4; see also Schnoll, supra note 2. 61. U.S. FOOD & DRUG ADMIN., supra note 4. 62. See Bryan Walsh, Food: The Senate Passes a Food-Safety Bill, But the Problem Isn't Going Away, TIME, Nov. 30, 2010, available at http://ecocentric.blogs.time.com/2010/11/30/food-the-senate-passes-a-long-awaited-food-safety-reform-bill-but-the-problem-isnt-going-a/#ixzz1amdxjqL3; see also JOHNSON, supra note 54, at 2. 63. Alison Young, Food Safety Groups Slam USDA Egg Graders at Farms in Recall, USA TODAY, Sept. 3, 2010, available at http://www.usatoday.com/yourlife/ food/safety/ 2010-09-02-eggregulations2_ST_N.htm (“Rep. Rosa DeLauro, who chairs the House Appropriations Agriculture subcommittee, last month sent a letter to Agriculture Secretary Tom Vilsack asking, among other things, about the egg graders’ awareness of conditions at Wright County Egg. She’s waiting on answers. It has never been more clear that we need to pass strong FDA food safety legislation this year,’ said DeLauro, D-Conn. ‘In the long term, a single food agency is needed that focuses exclusively on protecting our food supply.’”).
2012] A SCIENCE-BASED ENDEAVOR 545
easily.64
Food wholesalers, farm organizations, and cooperatives
opposed the expansion of FDA regulatory power.65
Some advocates for
small farms and organic food producers said this type of legislation
would destroy their industry under a mountain of paperwork.66
The
small government ideals remained a driving force behind many
Republicans who believed that the cost of this type of food safety act for
both the government and consumers would be too high.67
Nevertheless,
Representative John Dingell (D-MI) introduced the first attempt at
granting the FDA more preventative enforcement power on June 8,
2009.68
H.R. 2749, entitled “The Food Safety Enhancement Act,” was
referred to the House Committee on Energy and Commerce, and, after
committee amendment and general floor debate, the bill passed the
House of Representatives by a vote of 283-142 on July 30, 2009.69
Although this bill was referred to the Senate on August 3, 2009, the
Senate did not take any further action on it.70
Rather, Senator Dick
Durbin (D-IL) introduced a new bill on March 3, 2009, S.510, entitled
“The FDA Food Safety Modernization Act.”71
Senator Jon Tester (D-
MT) and Senator Kay Hagen (D-NC) advocated for a “Tester
Amendment” to this bill to exempt producers with less than $500,000 in
annual sales who sell most of their food locally.72
Despite the Tester
Amendment exemption for small farmers, Senator Tom Coburn (R-OK)
strongly opposed the legislation and forced a vote on an amendment to
ban all earmark spending through 2013 in attempts to prevent the bill
64. See Walsh, supra note 62. 65. H.R. 2751—FDA Food Safety Modernization Act, OPEN CONGRESS, http://www.opencongress.org/bill/111-h2751/show (last visited Oct. 31, 2012). 66. Gardiner Harris and William Neuman, Senate Passes Sweeping Law on Food Safety, N.Y. TIMES, Nov. 30, 2010, available at http://www.nytimes.com/2010/12/01/ health/policy/01food.html. 67. Helena Bottemiller, Update: Food Safety Bill Clears Full Senate, FOOD SAFETY
NEWS, Nov. 30, 2010, available at http://www.foodsafetynews.com/2010/11/s510-clears-key-vote-debate-to-resume-today/ (stating that during debates over the Act, Senator Tom Coburn (R-OK) argued that the bill “fails to address systemic problems with federal food safety oversight and will increase the cost of food as well as leave the states with unfunded mandates”). 68. Bill Summary and Status 111th Congress (2009-2010) H.R. 2749, THOMAS
(LIBRARY OF CONGRESS), http://thomas.loc.gov/home/thomas.php (last visited Nov. 11, 2011). 69. H.R.2749—Food Safety Enhancement Act, OPEN CONGRESS, http://www.opencongress.org/bill/111-h2751/show (last visited Dec. 1, 2011). 70. See id. 71. See Bill Summary and Status 111th Congress (2009-2010) S. 510, THOMAS
(LIBRARY OF CONGRESS), http://thomas.loc.gov/home/thomas.php (last visited Nov. 12, 2011). 72. FDA Food Safety Modernization Act, Pub. L. No. 111-353, 124 Stat. 3885 (2011) (codified as amended in scattered sections of 21 U.S.C.).
546 PENN STATE LAW REVIEW [Vol. 117:2
from passing.73
Ultimately, the bill passed in the Senate with a vote of
73-25 on November 30, 2010.74
However, a constitutional concern arose after the bill’s passage.
S.510 contained a tax provision; yet all revenue raising provisions must
originate in the House of Representatives.75
To solve this problem, the
House attached the language of the Food Safety Modernization Act to
H.R. 3082, the Full Year Continuing Appropriations Act, on December
8, 2010.76
The Senate, however, rejected the Full Year Continuing
Appropriations Act for objections to earmarks.77
Instead, the Senate
resurrected H.R. 2751, a “Cash for Clunkers” bill that had originated in
the House and replaced the bill’s language with that of the Food Safety
Modernization Act.78
The Senate passed this restructured bill through
unanimous consent on December 19, 2010, which the House
subsequently passed by a vote of 215-144 on December 21, 2010.79
President Obama signed the Food Safety Modernization Act into law on
January 4, 2011.80
The final version of the Food Safety Modernization Act (the “Act”)
enables the FDA to implement compliance standards designed to prevent
food contamination and grants the agency the power to enforce these
standards.81
As Michael R. Taylor, Deputy Commissioner for Foods at
the FDA, stated:
The law directs the FDA to issue a rule requiring comprehensive
preventive controls for most facilities. In the future, each facility will
have to produce a written analysis identifying the hazards associated
with the foods it handles and the processes used to manufacture them.
The required documentation will describe the controls the facility has
73. 156 CONG. REC. S8259-02 (daily ed. Nov. 30, 2010) (statement of Sen. Tom Coburn). 74. S.510—FDA Food Safety Modernization Act, OPEN CONGRESS, http://www.opencongress.org/bill/111-s510/show (last visited Nov. 23, 2011). 75. U.S. CONST. art. I, § 7. 76. See 156 CONG. REC. D1170-01 (daily ed. Dec. 8, 2010). 77. See Bill Summary and Status 111th Congress (2009-2010) H.R. 3082, THOMAS
(LIBRARY OF CONGRESS), http://thomas.loc.gov/home/thomas.php (last visited Oct. 31, 2012) (noting H.R. 3082 later passed without the language of the FDA Food Safety Modernization Act). 78. Jamie Dupree, Food Safety Bill Lives, THE ATLANTA JOURNAL-CONSTITUTION (Dec. 19, 2010, 8:39 PM), http://blogs.ajc.com/jamie-dupree-washington-insider/2010/12/19/food-safety-bill-lives/. 79. H.R.2751—FDA Food Safety Modernization Act, OPEN CONGRESS, http://www.opencongress.org/bill/111-h2751/show (last visited Oct. 31, 2012). 80. Elizabeth Weise, Obama Signs Legislation to Improve Food Safety, USA
TODAY, Jan. 5, 2011, available at http://www.usatoday.com/news/nation/2011-01-04-food-safety_N.htm. 81. FDA Food Safety Modernization Act, Pub. L. No. 111-353, 124 Stat. 3885 (2011) (codified as amended in scattered sections of 21 U.S.C.).
2012] A SCIENCE-BASED ENDEAVOR 547
implemented to prevent the identified hazards, including a plan for
monitoring the controls and correcting problems when failures
occur.82
Key aspects of the Act emphasize prevention, inspection and
compliance, response, regulations on foreign imports, and enhanced
partnerships with other government agencies (both domestic and
foreign).83
The Act requires the FDA to establish comprehensive, science-
based preventive controls across the food supply.84
This mandate
includes: (1) requiring food facilities to implement a written
preventative plan; (2) establishing science-based minimum standards for
the safe production and harvesting of fruits and vegetables; and,
(3) issuing regulations to protect against the intentional contamination of
food.85
As noted above, in the food facilities’ preventative safety plans,
the facilities must evaluate the hazards that could affect food safety and
implement preventive steps to minimize or prevent these hazards.86
The
facilities must also indicate how they will monitor these safety controls,
maintain routine records of the monitoring, and specify what actions they
will take to correct problems that arise.87
In addition, the FDA must
establish produce safety standards. In establishing mandatory produce
safety standards, the FDA must consider naturally occurring hazards, as
well as those that may be introduced either intentionally or
unintentionally.88
Moreover, the FDA must address soil amendments,
hygiene, packaging, temperature controls, animals in the growing area,
and water.89
The FDA will also have authority to prevent intentional
contamination and must establish science-based mitigation strategies to
prepare and protect the food supply chain at specific vulnerable points.90
However, these preventive control standards can improve food
safety only to the extent that producers and processors comply with the
standards. Consequently, the Act includes provisions that provide the
FDA with new tools for inspection and compliance, including:
(1) establishing a mandated inspection frequency; (2) allowing FDA
82. Michael R. Taylor, Will the Food Safety Modernization Act Help Prevent Outbreaks of Foodborne Illness?, NEW ENG. J. MED. (2011), available at http://www.nejm.org/doi/full/10.1056/NEJMp1109388#t= article. 83. U.S. FOOD & DRUG ADMIN., supra note 4. 84. Id. 85. Id. 86. See 124 Stat. at 3889. 87. See id. 88. U.S. FOOD & DRUG ADMIN., supra note 4. 89. See 124 Stat. at 3900 (stating soil amendments are materials added to the soil, such as compost). 90. See 124 Stat. at 3895.
548 PENN STATE LAW REVIEW [Vol. 117:2
access to records; and (3) requiring certain food testing to be carried out
by accredited laboratories.91
In addition, the FDA received a $50 million
funding boost for 2012, $39 million of which is specifically designated
for carrying out measures of the Food Modernization Act.92
The
frequency of food facility inspections will be based on the level of risk
associated with the facility, and an increased risk level will result in
immediate increase in inspection frequency.93
All high-risk domestic
facilities must be inspected within five years of the date of enactment and
no less than every three years after that.94
The FDA will have access to
records and food safety plans, and food facilities must document the
implementation of their plans.95
To carry out certain food tests, the FDA
must also establish a program for laboratory accreditation to ensure that
U.S. food testing laboratories meet high quality standards.96
Section III of this Comment focuses on Title I, Section 103 of the
Act, entitled “Hazard Analysis and Risk Based Preventative Controls.”
Section 103 of the Act amends the basic 1938 Act to mandate that food
facilities implement “science-based” food safety plans.97
Section 103 is
critical because, “for the first time, [the] FDA has a legislative mandate
to require comprehensive, prevention-based controls across the food
supply.”98
The language of Section 103 enumerates, “Not later than 18
months after January 4, 2011, the Secretary shall promulgate regulations
to establish science-based minimum standards for conducting a hazard
analysis, documenting hazards, implementing preventive controls, and
documenting the implementation of the preventive controls under this
section.”99
Thus, the remainder of this Comment will analyze the
language of Section 103 to clarify and discover its meaning as the FDA
plans to promulgate both guidance documents and regulations.
91. U.S. FOOD & DRUG ADMIN., supra note 4. 92. Caroline Scott-Thomas, Food Safety Law Gets $39m Funding for 2012, FOOD
NAVIGATOR USA (Dec. 2, 2011) http://www.foodnavigator-usa.com/ Regulation/Food-safety-law-gets-39m-funding-for-2012. 93. U.S. FOOD & DRUG ADMIN., supra note 4. 94. See 124 Stat. at 3888. 95. See id. at 3886. 96. U.S. FOOD & DRUG ADMIN., supra note 4. 97. 124 Stat. at 3895. 98. Food Safety Legislation Key Facts, U.S. FOOD & DRUG ADMIN. http://www.fda.gov/Food/FoodSafety/FSMA/ucm237934.htm (last updated July 19, 2011). 99. 124 Stat. at 3895.
2012] A SCIENCE-BASED ENDEAVOR 549
III. ANALYSIS
Congress’s mandate to the FDA to promulgate safety regulations
may seem relatively straightforward at first glance.100
The Food Safety
and Modernization Act (the “Act”) clearly states that the FDA must
establish food safety regulations and provides the final date for the
publication of these regulations.101
The Act also includes language to
alleviate undue burdens on small food producing facilities.102
However,
the Act leaves some ambiguity involving the substantive nature of the
regulations themselves.103
The only qualitative description of the
regulations that the Act specifies is that the regulations must be “science-
based.”104
This terminology is broad and allows the FDA to determine
the specifics of the regulations to be promulgated.105
The broad term “science-based” grants the FDA the power to
determine the specific nature of the preventive regulations.106
It does not
provide substantive direction to the FDA regarding the specific content
of the regulations, such as requisite probability levels or establishing
burden of proof.107
Because of the open-ended nature of this directive,
there could be challenges in court regarding the meaning of the term
“science-based,” and whether the FDA regulations adhere to this
meaning.108
The FDA’s regulations will have a great impact on food
production companies, and these companies will likely scrutinize the
regulations closely for overstepping the Congressional mandate.109
On
the other hand, public interest groups will examine the regulations for
100. See id. 101. See id. (“Not later than 18 months after January 4, 2011, the Secretary shall promulgate regulations.”). 102. See id. (noting that the regulations shall “provide sufficient flexibility to be practicable for all sizes and types of facilities, including small businesses such as a small food processing facility co-located on a farm”). 103. See Shawn Stevens, The Food Safety Modernization Act: Are We Almost There Yet?, DEFENDING FOOD SAFETY (Nov. 15, 2011), http://www.defendingfoodsafety.com/ 2011/11/articles/food-safety-news/the-food-safety-modernization-act-are-we-almost-there-yet/. 104. See Shawn Stevens, We Think We Have an Adequate Food Safety Plan, But How Will It Be Enforced?, DEFENDING FOOD SAFETY (Sept. 28, 2011), http://www.defendingfoodsafety.com/2011/09/articles/food-safety-news/we-think-we-have-an-adequate-food-safety-plan-but-how-will-it-be-enforced/. 105. See id. 106. See Laetitia Mailhes, The Food Safety Act Raises Questions, CARE2.COM (Dec. 1, 2010, 9:36 AM), http://www.care2.com/greenliving/the-food-safety-modernization-act-raises-questions.html#ixzz1lEvKJ8Dg. 107. See 124 Stat. at 3895. 108. See H.R.2751—FDA Food Safety Modernization Act, supra note 79; H.R.2749—Food Safety Enhancement Act, supra note 69. 109. See id.
550 PENN STATE LAW REVIEW [Vol. 117:2
falling short of Congress’s aim in protecting public health and safety.110
The pervasive impact of these regulations could result in challenges to
the scope of Congress’s mandate to the FDA.111
Challenges to agency
authority in court are common.112
The Supreme Court has established
precedent in determining the level of deference that an agency receives
when interpreting a statute the agency administers.113
Part III of this Comment seeks to clarify the broad term “science-
based” as used by Congress to authorize the FDA to promulgate food
safety regulations. Specifically, Part III will use the first prong of
Chevron and the three archeological methods114
of statutory
interpretation––textualism, intentionalism, and purposivism—to discover
the meaning of the term “science-based” within the context of the Act.
First, Part III will establish the importance of discussing “science-based”
under the first prong of Chevron using the three statutory interpretation
methods as a framework. Next, Part III will examine the term “science-
based” under each method of statutory interpretation and discuss the
implications of each of these methods. Part III will clarify the range of
meaning for the term “science-based” in the context of the FDA Food
Safety Modernization Act.115
A. Agency Deference
The Supreme Court has established precedent for the standard of
review that a court should apply to a government agency’s interpretation
of a statute that the agency administers.116
In Chevron U.S.A., Inc. v.
110. See id. 111. See, e.g., Helena Bottemiller, Senate Food Safety Bill Moves Ahead, FOOD
SAFETY NEWS (Nov. 18, 2010), http://www.foodsafetynews.com/2010/11/food-safety-bill-advances-compromises-ironed-out/ (stating the widespread impact of the bill, and explaining why some were opposed to its passage). 112. See, e.g., Chevron U.S.A., Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837 (1984); Estate of Cowart v. Nicklos Drilling Co., 505 U.S. 469 (1992); Skidmore v. Swift & Co., 323 U.S. 134 (1944); Christensen v. Harris Cnty., 529 U.S. 576 (2000); United States v. Mead Corp., 533 U.S. 218 (2001); Nat’l Cable & Telecommunications Ass’n v. Brand X Internet Servs., 545 U.S. 967 (2005). 113. See id. 114. “Archeological” methods of statutory interpretation, as termed by William N. Eskridge, refer to a court’s objective to “unearth and enforce the original intent or expectations of the legislature that created the statute.” William N. Eskridge, Jr., Politics Without Romance: Implications of Public Choice Theory for Statutory Interpretation, 74 VA. L. REV. 275 (1988). 115. This Comment serves to establish the basic limits on the FDA’s “science-based” regulations, and, while further analysis of the term “science-based” under the second prong of Chevron and under various other methods of statutory interpretation would also prove insightful, such analysis is beyond the scope of this Comment. 116. See Chevron, 467 U.S. at 842.
2012] A SCIENCE-BASED ENDEAVOR 551
Natural Resources Defense Council, Inc., the Court enumerated a two-
part analysis:
First, always, is the question whether Congress has spoken directly to
the precise question at issue. If the intent of Congress is clear, that is
the end of the matter; for the court as well as the agency must give
effect to the unambiguously expressed intent of Congress. If,
however, the Court determines Congress has not directly addressed
the precise question at issue, the court does not simply impose its
own construction of the statute, as would be necessary in the absence
of an administrative interpretation. Rather, if the statute is silent or
ambiguous with respect to the specific question, the issue for the
court is whether the agency’s answer is based on a permissible
construction of the statute.117
The Court limited and clarified Chevron in two later decisions, holding
that deference to an agency’s interpretation only applies if it is the
product of a formal agency process118
in which the agency is authorized
by Congress “to speak with the force of law.”119
In the case of FDA food
safety regulations, the FDA would be accorded Chevron deference
because the regulations it promulgates are currently in the notice-and-
comment formal rulemaking process, and Congress authorized the FDA
to speak with the force of law.120
The first prong of the Chevron analysis asks whether Congress has
directly addressed the issue at hand, in this case, the meaning of the term
“science-based.”121
Although the Court appears to favor agency
deference in the ultimate holding of Chevron, the Court has often
determined that Congress had indeed addressed the question at issue,
requiring no need to defer to agency interpretation.122
The methods that
the Court uses to determine whether Congress directly addressed an issue
are instrumental in making this determination. The Court has not relied
on a single method of determining congressional intent, using both
legislative history and plain meaning in various decisions.123
117. Id. 118. Formal agency processes include adjudication or notice-and-comment rulemaking. See Mead Corp., 533 U.S. 218. 119. Id. at 229 (2001); see also Christensen, 529 U.S. 576 (2000). 120. See Press Release, Food & Drug Admin., Dockets Open for Comment (July 12, 2011), available at http://www.fda.gov/Food/FoodSafety/FSMA/ucm261689.htm. 121. See Chevron, 467 U.S. at 842. 122. See, e.g., Sullivan v. Zebley, 493 U.S. 521 (1990) (noting that regulations “are simply inconsistent with the statutory standard”); Dole v. Steelworkers, 494 U.S. 26 (1990) (stating that deference to OMB interpretation of Paperwork Reduction Act is foreclosed by the Court’s finding of clear congressional intent to contrary). 123. See, e.g., Dunn v. CFTC, 519 U.S. 465, 473-74 (1997) (stating legislative history supports the Court’s conclusion that the statute is clear and the agency’s interpretation is untenable); see also Babbitt v. Sweet Home Chapter, 515 U.S. 687, 708 (1995)
552 PENN STATE LAW REVIEW [Vol. 117:2
Therefore, three archeological methods of statutory interpretation
provide useful lenses in which to explore whether Congress “directly
addressed” a particular issue.124
The first of these is “textualism.”
Textualism involves an analysis of the text itself and puts great emphasis
on the plain meaning of the language.125
The second method is
“intentionalism.” Intentionalists “rely on the historical record of the
lawmaking process,” including reference to congressional records,
committee hearings, and committee reports to determine congressional
intent.126
Finally, the third method is known as “purposivism.” This
method looks deeper into the purpose of the statute, and contemplates the
statute’s political history.127
Each of these methods can be used to
analyze the term “science-based” to clarify the meaning of FDA
regulation requirements.
B. Textualism
An examination of the text of the Food Safety Modernization Act
(the “Act”) provides insight into the practical implications of a “science-
based” regulation. The study and emphasis on the plain meaning of text
to determine a statute’s implication is “textualism.”128
As Justice Scalia
stated, the goal of textualism is to determine “the intent that a reasonable
person would gather from the text of the law, placed alongside the
remainder of the corpus juris.”129
The Supreme Court sometimes relies
upon this method to determine the meaning of a statute.130
In
(concluding that “based on the text, structure, and legislative history of the ESA, that the Secretary reasonably construed the intent of Congress” in defining “harm”); K Mart Corp. v. Cartier, Inc., 486 U.S. 281, 291 (1988) (stating that courts should look “to the particular statutory language at issue, as well as the language and design of the statute as a whole” in order to ascertain statute’s “plain meaning”); Ohio Pub. Emps. Ret. Sys. of Ohio v. Betts, 492 U.S. 158, 171 (1989) (“[N]o deference is due to agency interpretations at odds with the plain language of the statute itself.”). 124. See Eskridge & Frickey, supra note 11, at 324. 125. See Nelson, supra note 11, at 347; see also Eskridge & Frickey, supra note 11, at 340. 126. See Solan, supra note 11, at 427. 127. See Strauss, supra note 11, at 242; see also Eskridge & Frickey, supra note 11, at 332. 128. See John F. Manning, Textualism and Legislative Intent, 91 VA. L. REV. 419, 420 (2005) (discussing the ideas about legislative intent that follow from underlying textualist assumptions). 129. Antonin Scalia, Common-Law Courts in a Civil-Law System: The Role of United States Federal Courts in Interpreting the Constitution and Laws, in A MATTER OF
INTERPRETATION: FEDERAL COURTS AND THE LAW 17 (Amy Gutmann ed., 1997). 130. See, e.g., Nat’l R.R. Passenger Corp. v. Bos. & Me. Corp., 503 U.S. 407 (1992) (holding an agency’s permissible construction of a silent or ambiguous statute is entitled to deference if not in conflict with the plain language of the statute); Pub. Emps. Ret. Sys. of Ohio v. Betts, 492 U.S. 158 (holding no deference to agency interpretation at odds with plain language of statute it administers); Demarest v. Manspeaker, 498 U.S. 184
2012] A SCIENCE-BASED ENDEAVOR 553
determining the significance of statutory language, textualists recognize
the importance of placing the text in context; however, textualists do not
believe that legislative history plays any role in shaping that context.131
Rather, textualists look to dictionaries, the statute as a whole, or other
statutes in which similar language is used.132
Analyzing the Act in this
way will shed light on the difficultly presented by the term “science-
based” in this context.
Looking solely at the text of Section 103 of the Act, the standard for
the regulations that Congress requires of the FDA is minimal. A simple
definition of the term “science” is “knowledge or a system of knowledge
covering general truths or the operation of general laws especially as
obtained and tested through scientific method.”133
Common
understanding of the term recognizes the importance of objectivity,
rather than subjectivity, in the meaning of “science-based” regulations.
This broad characterization of the term provides the FDA with extensive
authority to promulgate objectively founded regulations.
Section 103 of the Act does not contain many restrictive provisions
alongside the term “science-based.”134
Aside from specifications stating
that the regulations must accommodate all facility sizes and must not
require that facilities hire third-party consultants, the Act does not greatly
restrict the extent of FDA oversight.135
If the FDA regulations, whether
minimalistic or overly burdensome, meet the objectivity standard and fall
within the few limitations set forth in Section 103, a textualist
interpretation would likely deem the regulation satisfactory. Many
judges and academics argue in favor of a purely textualist approach to
statutory interpretation,136
but this method can only provide a certain
degree of direction for the regulations. An analysis of the legislative
history of the Act will provide additional information for the meaning of
the term “science-based,” though texualists would dispute whether
legislative history should contribute to the understanding of the term’s
meaning.
(1991) (holding administrative interpretation of statute contrary to its plain language is not entitled to deference); MCI Telecomm. Corp. v. Am. Tel. & Tel. Co., 512 U.S. 218 (1994) (holding agency’s interpretation of statute is not entitled to deference when it goes beyond meaning that statute can bear). 131. See Scalia, supra note 129, at 23. 132. See William N. Eskridge, Jr., The New Textualism, 37 UCLA L. REV. 621, 669 (1990). 133. Science Definition, MERRIAM-WEBSTER DICTIONARY, http://www.merriam-webster.com/dictionary/science (last visited Oct. 31, 2012). 134. See FDA Food Safety Modernization Act, Pub. L. No. 111-353, 124 Stat. 3885, 3895 (2011). 135. Id. 136. See, e.g., Scalia, supra note 129, at 23; Jonathan R. Siegel, Textualism and Contextualism in Administrative Law, 78 B.U. L. REV. 1023, 1026 (1998).
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C. Intentionalism
Courts regularly use legislative history to clarify and articulate the
meaning of a term in a statute.137
In the case of vague terminology,
Lawrence M. Solan argues, “When a statute is ambiguous, an
interpretive effort is unavoidable.”138
Moreover, proponents of the use of
intentionalism believe that legislative history is important because “[i]f
the legislature is the primary lawmaker and courts are its agents, then
requiring the courts to follow the legislature’s intentions disciplines
judges by inhibiting judicial lawmaking, and in so doing seems to further
democracy by affirming the will of elected representatives.”139
Committee hearings, congressional reports, floor statements, and earlier
versions of a bill provide evidence of the legislative process and
congressional intent.140
However, committee reports are the most widely
utilized source of legislative history.141
Justices avoid relying on floor
statements cited in congressional reports and do not prefer to rely on
floor statements alone, as these tend to reflect individualistic views.142
Likewise, purely private understandings of legislators are not enforced
through this method of analysis.143
Public legislative records pertaining
to the Food Safety and Modernization Act (the “Act”) contain various
references to the term “science-based” that can serve to help clarify the
definition of this term.144
137. See, e.g., NationsBank of N.C., N.A. v. Variable Annuity Life Ins. Co., 513 U.S. 251 (1995) (holding legislative history may indicate whether an agency’s interpretation of a statute that is silent or ambiguous on the issue in question is reasonable for the purposes of Chevron deference); Reno v. Koray, 515 U.S. 50 (1995) (holding legislative history, particularly changes relating to the agency interpretation at issue, may be helpful in determining whether the agency’s interpretation is plausible and entitled to deference); Clarke v. Sec. Indus. Ass’n, 479 U.S. 388 (1987) (holding legislative history may be indicative of the reasonableness of the agency’s interpretation of a statute in determining whether that interpretation is entitled to deference). 138. Solan, supra note 11, at 485. 139. Eskridge & Frickey, supra note 11, at 326. 140. See Richard A. Posner, Statutory Interpretation-in the Classroom and in the Courtroom, 50 U. CHI. L. REV. 800, 819-20 (1983) (discussing a positive proposal on how to interpret statutes). 141. See Jane S. Schacter, The Confounding Common Law Originalism in Recent Supreme Court Statutory Interpretation: Implications for the Legislative History Debate and Beyond, 51 STAN. L. REV. 1, 15 (1998); see also ABNER J. MIKVA & ERIC LANE, AN
INTRODUCTION TO STATUTORY INTERPRETATION AND THE LEGISLATIVE PROCESS 36 (1997). 142. See Schacter, supra note 141. 143. WILLIAM N. ESKRIDGE, JR., ET AL., LEGISLATION AND STATUTORY
INTERPRETATION 296-97 (2000) (stating that it is “rare” for federal judges to make determinations based on information that is not publicly accessible). 144. See hearings cited infra notes 147, 149, 151.
2012] A SCIENCE-BASED ENDEAVOR 555
First, various congressional records use the term “science-based”
while referring to the Hazard Analysis and Critical Control Point
(HACCP) methodology. HACCP is a risk control mechanism currently
used both by the U.S. Department of Agriculture (USDA) to regulate
meat production facilities and by the FDA to regulate seafood and juice
production facilities.145
In a hearing on April 2, 2009, before the
Committee on Agriculture in the U.S. House of Representatives,
Chandler Keys, representing JBS USA LLC,146
described his own
company’s procedures after stating that he would assist Congress in
establishing “science-based” measures.147
The procedures used by JBS
reflect risk assessment mechanisms as outlined in HACCP.148
In an
April 23, 2009 House hearing, James O. Regan of the National
Cattlemen’s Beef Association used “science-based” in reference to
intervention and management strategies, stating “utilizing science-based
principles and validating interventions used throughout the [beef
production] process effectively controls the associated risks of E.
coli.”149
These “science-based principles” are the same methods outlined
in HACCP. At another House hearing on July 16, 2009, Robert G.
Reinhard of the Sara Lee Corporation150
plainly stated, “HACCP is a
science-based proven food safety system that has enhanced the safety of
the meat and poultry products produced in the United States.”151
Various
references to “science-based” methods throughout food safety committee
hearings refer to the methods used by HACCP, so a further examination
of this methodology will clarify the meaning of this term.
145. Hazard Analysis and Critical Control Point (HACCP) Systems, 21 C.F.R. § 120.1 (2001). 146. JBS USA LLC is a large meat processing company. Visit the JBS website at http://www.jbssa.com. 147. Hearing to Review Current Food Safety Systems: Hearing Before the H. Comm. on Agric., 111th Cong. 4 (2009) [hereinafter April 2 Hearing] (testimony of Chandler Keys, Head of Gov’t Affairs & Indus. Relations, JBS USA LLC). 148. Food Safety, JBS, http://www.jbssa.com/Responsibility/FoodSafety/default.aspx (last visited Oct. 31, 2012). 149. Hearing to Review Federal Food Safety Systems at the Department of Agriculture: Hearing Before the Subcomm. on Livestock, Dairy, & Poultry of the H. Comm. on Agric., 111th Cong. 34 (2009) [hereinafter April 23 Hearing] (testimony of James O. Regan, Senior Vice President of Research, Educ., & Innovation, Nat’l Cattlemen’s Beef Assoc.). 150. Sara Lee is a food and beverage production company. See SARA LEE, http://www.saralee.com/ (last visited Oct. 31, 2012). 151. Hearing to Review Current Issues in Food Safety: Hearing Before the H. Comm. on Agric., 111th Cong. 51 (2009) [hereinafter July 16 Hearing] (testimony of Robert G. Reinhard, Dir. of Food Safety & Regulatory Affs., Sara Lee Corp.).
556 PENN STATE LAW REVIEW [Vol. 117:2
HACCP methodology outlines a “systematic approach to the
identification, evaluation, and control of food safety hazards.”152
Pillsbury and NASA jointly developed HACCP in the 1960s in a project
aimed at keeping astronaut’s food pathogen-free.153
This program
attempted to identify the processing points where food safety risks could
be reduced to the greatest extent possible, much like the requirements of
the FDA Food Safety Modernization Act.154
According to the HACCP
Principles and Application Guidelines:
[T]he major infusion of science in a HACCP system centers on
proper identification of the hazards, critical control points, critical
limits, and instituting proper verification procedures. These
processes should take place during the development and
implementation of the HACCP plans and maintenance of the HACCP
system.155
To be science-based, HACCP plans include “(1) expert advice and
scientific studies and (2) in-plant observations, measurements, and
evaluations.”156
For example, in the meat industry, “validation of the
cooking process for beef patties should include times and temperatures
needed to obtain an appropriate destruction of pathogenic
microorganisms (i.e., enteric pathogens) and studies to confirm that the
conditions of cooking will deliver the required time and temperature to
each beef patty.”157
Although HACCP standards play a role in clarifying the term
“science-based,” differences between this methodology and the
regulations that the FDA will need to promulgate should be considered.
HACCP has been widely successful in the meat industry; however, meat
facilities produce a limited set of distinct products, as opposed to the
wide variety of different products and facilities that the FDA will soon
152. U.S. FOOD & DRUG ADMIN., HAZARD ANALYSIS AND CRITICAL CONTROL POINT
PRINCIPLES AND APPLICATION GUIDELINES (1997), available at http://www.fda.gov/Food/ FoodSafety/HazardAnalysisCriticalControlPointsHACCP/HACCPPrinciplesApplicationGuidelines/default.htm. 153. See William H. Serber & Richard F. Stier, Happy 50th Birthday to HACCP: Retrospective and Prospective, FOOD SAFETY MAG. (Jan. 2009), available at http://www.foodsafetymagazine.com/article.asp?id=3481. 154. Id. (stating that the seven principles that guide HACCP to eliminate food safety risks today are: (1) conduct a hazard analysis; (2) determine the CCPs; (3) establish critical limit(s); (4) establish a system to monitor control of the CCPs; (5) establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control; (6) establish procedures for verification to confirm that the HACCP system is working effectively; and (7) establish documentation concerning all procedures and records appropriate to these principles and their application). 155. U.S. FOOD & DRUG ADMIN., supra note 152. 156. Id. 157. Id.
2012] A SCIENCE-BASED ENDEAVOR 557
regulate.158
All meat production facilities use similar procedures and
face similar risks, and therefore follow similar HACCP programs.159
Meanwhile, the regulations under the Food Safety Modernization Act
must operate in food facilities of all types and sizes.160
While the
HACCP methodology does not provide solutions for all aspects of food
regulation, it is one process that could qualify as “science-based.”
The term “science-based” also surfaces often in reference to the
Food Safety and Inspection Service (FSIS).161
The FSIS is a public
health agency of the USDA responsible for overseeing the safe
production of meat, poultry, and eggs.162
In a House Agriculture
Committee hearing on July 16, 2009, Patrick Boyle, President and CEO
of the American Meat Institute, stated:
FSIS assures processes are scientifically validated. Teams of expert
auditors conduct periodic in-depth food safety assessments which can
take days or weeks to complete and may involve extensive
microbiological sampling of the plant’s environment and finished
products. Annually, FSIS conducts more than 8,000 microbiological
tests to verify the production processes are under control. This is in
addition to the several million microbiological tests that industry
conducts each year.163
Later in the same hearing, Robert Reinhard of the Sara Lee Corporation
described FSIS as a “modern science-based inspection service.”164
Further discussion of FSIS at an April 23, 2009 Agriculture Committee
hearing reveals an emphasis on empirical science-based data collection,
free from subjective influence.165
FSIS administrator Alfred V. Almanza
addressed the importance of uniformity in data collection, explaining:
[T]he [Enforcement Investigation Analysis Officers (EIAOs)], they
are all trained in the same manner. In fact, we just had a new
enhanced training session for our EIAOs to be able to do it in a very
uniform manner, whether it be in Virginia or whether it be clear
158. See Stevens, supra note 104. 159. U.S. FOOD & DRUG ADMIN., supra note 152. 160. See FDA Food Safety Modernization Act, Pub. L. No. 111-353, 124 Stat. 3885 (2011) (codified as amended in scattered sections of 21 U.S.C.). 161. See supra notes 147, 149, 151. 162. See FOOD SAFETY & INSPECTION SERV., http://www.fsis.usda.gov/ (last visited Nov. 1, 2012). 163. July 16 Hearing, supra note 151, at 16 (testimony of Patrick Boyle, President and CEO, Am. Meat Inst.). 164. July 16 Hearing, supra note 151, at 48 (testimony of Robert G. Reinhard, Dir. of Food Safety & Regulatory Affs., Sara Lee Corp.). 165. April 23 Hearing, supra note 149, at 20 (testimony of Alfred V. Almanza, Admin., Food Safety & Inspection Serv.).
558 PENN STATE LAW REVIEW [Vol. 117:2
across the country in California. We want a uniform way of food
safety.166
“Science-based” terminology is found in reference to the FSIS
throughout food safety legislative history, and analysis of the science
methods used by this agency provides further insight to the term.
The FSIS is “the public health regulatory agency responsible for
ensuring that domestic and imported meat, poultry and processed egg
products are safe, wholesome and correctly labeled and packaged.”167
FSIS relies heavily on data collection to detect and respond to food
contamination hazards.168
FSIS methodology involves a data analytics
technique called the Public Health Information System, a web-based
application establishing an automated data-driven inspection system.169
This system allows “analysts to identify trends that will automatically
adjust domestic and import inspections and sampling, such as the
relationship between Salmonella test results and inspection findings,
notifying field and headquarters personnel about potential public health
threats.”170
The reference to FSIS methodology using the term “science-
based” in the legislative history suggests that data usage is an important
aspect of this term.
Another use of the term “science-based” in the legislative history
appears in reference to the importance of maintaining sufficient
infrastructure to establish the proper “science-based” standards.171
On
April 23, 2009, Professor Michael Taylor testified:
[A]s documented by the FDA Science Board, a group of independent
experts from outside FDA, FDA’s science base for food safety has
eroded over the years; it has miniscule resources for applied food
safety research; and it lacks the modern information systems that are
essential to implementation of a science-based and preventive food
safety program.172
As noted by Professor Taylor, the FDA Science Board issued a report
stating that the FDA “does not have sufficiently extensive collaboration
166. Id. 167. Press Release, USDA Food Safety & Inspection Serv., Food Safety and Inspection Service’s Public Health Information System (Sept. 3, 2010). 168. Id. 169. Id. 170. Id. 171. See Keeping America’s Families Safe: Reforming the Food Safety System: Hearing Before the S. Comm. on Health, Educ., Labor, & Pensions, 111st Cong. 75 (2009) [hereinafter October 22 Hearing] (testimony of Kraig R. Naasz, President and CEO, Am. Food Inst.). 172. April 23 Hearing, supra note 149, at 53 (testimony of Michael R. Taylor, Research Prof., Dep’t of Health Policy at George Washington Univ. Sch. of Pub. Health & Health Servs.).
2012] A SCIENCE-BASED ENDEAVOR 559
with external scientists, thus limiting infusion of new knowledge and
missing opportunities to leverage resources.”173
The report also noted
that the FDA “has insufficient access to data and cannot effectively
regulate products based on new science due to lack of a supportive IT
infrastructure.”174
As Kraig Naasz, President and CEO of the American
Frozen Food Institute stated in an October 22, 2009 Senate Committee
hearing, “The single step that could most dramatically improve FDA’s
effectiveness in scrutinizing the safety of food imports would be to
provide the agency modern information technology capabilities.”175
The
emphasis in the legislative history on employing proper infrastructure to
establish “science-based” standards further refines the meaning of this
term.
Another possible meaning for the term “science-based,” as
described in the legislative history, could be FDA use of modern
information technology and partnership formation with external
scientists.176
Collaboration with scientists outside of the FDA would
ensure that the science employed would be the most current technologies
available.177
Up-to-date scientific data is key for standards promulgated
under the Food Safety and Modernization Act,178
and partnerships with
other agencies, academia, and industry would help ensure that these
standards are “science-based.”179
In addition, access and organization of
data is crucial to establishing “science-based” principles, and adequate
information technology is critical in reaching this objective.180
Legislators’ discussions of the importance of modern information
technology, data analysis, and hazard analysis risk assessment in the
context of “science-based” regulations suggest that these methods are
important components of “science-based” regulations.
173. FDA SCIENCE BOARD, FDA SCIENCE AND MISSION AT RISK: REPORT OF THE
SUBCOMMITTEE ON SCIENCE AND TECHNOLOGY 44 (2007). 174. Id. 175. October 22 Hearing, supra note 171, at 75 (testimony of Kraig R. Naasz, President and CEO, Am. Food Inst.). 176. Id. 177. FDA SCIENCE BOARD, supra note 173, at 44. 178. The Food Safety and Modernization Act requires preventative controls be “consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis.” FDA Food Safety Modernization Act, Pub. L. No. 111-353, 124 Stat. 3885, 3896 (2011). 179. FDA SCIENCE BOARD, supra note 173, at 44. 180. Id. at 49.
560 PENN STATE LAW REVIEW [Vol. 117:2
D. Purposivism
Finally, an analysis of the Food Safety and Modernization Act’s
purpose can further clarify the meaning of the term “science-based.”181
This method of statutory interpretation involves “decid[ing] what
purpose ought to be attributed to the statute and to any subordinate
provision of it which may be involved” and “interpret[ing] the words of
the statute immediately in question so as to carry out the purpose as best
it can.”182
Purposivism seeks to advance legislative preferences and
goals to carry out the legislature’s objective.183
Discussion of the
legislature’s purpose differs from an analysis of the legislature’s intent in
that “intent” refers to the legislature’s specific understanding of what it
meant in a particular circumstance, whereas purpose reflects what the
legislature ultimately sought to accomplish.184
Examining “science-
based” in light of Congress’s purpose in passing the Food Safety
Modernization Act will provide further clarification of this text.
Over the course of the legislative history of the Food Safety
Modernization Act (the “Act”), the nature of the globalized food market
arose in discussion. In the Senate Committee on Health, Education,
Labor, and Pensions hearing on food safety, Committee Chairman Tom
Harkin noted:
Over the last 100 years, our meals have gotten more complex in this
world. They include more varied ingredients, so they’re subject to
more diverse methods of processing and preparation. Today, raw
agricultural products travel thousands of miles, from farms to
processors to factories to the table. They’re routinely processed and
mixed along the way. In addition, we rely more and more on foods
imported from abroad.185
At the House Subcommittee on Livestock, Dairy, and Poultry hearing,
Jill Appell of the National Pork Producers Council further stated, “The
U.S. pork industry today provides about 20 billion pounds of safe,
181. See Ragsdale v. Wolverine World Wide, Inc., 535 U.S. 81 (2002) (striking down a Labor Department regulation for imposing a penalty that was against the remedial intent of Congress in enacting the controlling legislation). 182. HENRY HART & ALBERT SACKS, THE LEGAL PROCESS: BASIC PROBLEMS IN THE
MAKING AND APPLICATION OF LAW 1374 (William N. Eskridge, Jr. & Philip P. Frickey eds., 1994). 183. Michael Herz, Purposivism and Institutional Competence in Statutory Interpretation, 2009 MICH. ST. L. REV. 89, 92 (2009). 184. Id. at 93. 185. October 22 Hearing, supra note 171, at 6 (testimony of Sen. Tom Harkin, D-IA, Chairman, S. Comm. on Health, Educ., Labor, & Pensions).
2012] A SCIENCE-BASED ENDEAVOR 561
wholesome and nutritious meat protein to consumers worldwide.”186
Given today’s globalized food market, the purpose of the Act likely
considered food safety in the United States as a part of the international
economy.187
The World Trade Organization (WTO) establishes a range
of international food safety standards.188
Although scarcely mentioned in
the legislative history,189
ignoring WTO standards would undermine the
purpose of the Act, as the United States could face a WTO dispute if it
violates WTO agreements.
The Sanitary and Phytosanitary Agreement (the “Agreement”) of
the WTO requires the scientific justification of regulatory measures
based on a risk assessment.190
Article 5, Section 2 of the Agreement
states, “In the assessment of risks, Members shall take into account
available scientific evidence; relevant processes and production methods;
[and] relevant inspection, sampling and testing methods.”191
Article 2,
Section 2 of the Agreement further emphasizes that sanitary measures are
not to be “maintained without sufficient scientific evidence.”192
The
purpose of establishing food safety recognizes the United States position
on an international level, so “science-based” regulations that reflect the
methods established by the Agreement would likely fulfill the
legislature’s purpose.
IV. CONCLUSION
As the FDA works to promulgate “science-based” regulations, it
must ensure that the methods it establishes fall within the meaning of that
term in accordance with the Food Safety Modernization Act (the “Act”).
As argued in this Comment, this task proves more difficult than it might
first appear. Like any broad legislative terminology, the term “science-
based” could expose the FDA regulations to challenge in court by
disgruntled food production companies or public health advocates.
186. April 23 Hearing, supra note 149, at 37 (testimony of Jill Appell, former President, Nat’l Pork Prod. Council). 187. Id. 188. Committee on Sanitary and Phytosanitary Measures, Note by the Secretariat: Specific Trade Concerns, G/SPS/GEN/204/Rev.11/Corr.1 (adopted June 1, 2011). 189. The only mention of the WTO in the legislative history occurred in two committee meetings, though neither of these meetings discussed the WTO in detail. See April 2 Hearing, supra note 147, at 41; October 22 Hearing, supra note 171, at 74. 190. Agreement of the Application of Sanitary and Phytosanitary Measures, Apr. 15, 1994, 1867 U.N.T.S. 493 [hereinafter Phytosanitary Measures]; see also Jacqueline Peel, Risk Regulation Under the WTO SPS Agreement: Science as an International Normative Yardstick?, at 2 (The Jean Monnet Program, Working Paper No. 1087-2221, 2004). 191. Phytosanitary Measures, supra note 190, at 70. 192. Id. at 71.
562 PENN STATE LAW REVIEW [Vol. 117:2
While many canons of statutory interpretation and theories of
agency deference could factor into scrutiny of such challenges, three
commonly used methods of analysis demonstrate varying aspects of the
meaning of the text in this instance. The textualist perspective displays
the complex nature of the problem posed by a term with such broad
meaning.193
An intentionalist analysis aids in identifying specific factors
the legislature considered while discussing the meaning of the text,
including HACCP risk assessments, FSIS data analysis mechanisms, and
the importance of modern information technology.194
The purposivist
view considers the underlying objectives of the legislature, including the
United States’ position as an actor in the international food market.195
Upon promulgation of the final regulation and subsequent challenge
in court, further study of the legislative history and underlying purpose of
the Act will present additional insight into the meaning of “science-
based” regulations. The analysis can then be tailored specifically to the
nature of the challenge. Not all judges give equal weight to these three
methods of interpretation. Some, including Justice Scalia, favor one
method so strongly that they refuse to use any of the others.196
However,
strong arguments lie in each approach and all help provide a more
meaningful connotation to the term “science-based.” The varying
techniques of textualism, intentionalism, and purposivism each provide a
clearer meaning of the term “science-based,” presenting important
considerations for future analysis.
193. See supra Part III.B. 194. See supra Part III.C. 195. See supra Part III.D. 196. See Scalia, supra note 129, at 23.
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